Notice2022-23919
Agency Information Collection Activities; Proposed Collection; Comment Request; Federal-State Food Regulatory Program Standards
Primary source
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Published
November 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions associated with FDA's Federal-State Food Regulatory Program Standards.
Full Text
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<title>Federal Register, Volume 87 Issue 212 (Thursday, November 3, 2022)</title>
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[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66307-66309]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23919]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0341]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Federal-State Food Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the information collection provisions associated
with FDA's Federal-State Food Regulatory Program Standards.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State Food
Regulatory Program Standards.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
[[Page 66308]]
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#441416051730252222042220256a2c2c376a232b32"><span class="__cf_email__" data-cfemail="441416051730252222042220256a2c2c376a232b32">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Federal-State Food Regulatory Program Standards
OMB Control Number 0910-0760--Revision
This information collection supports FDA's Animal Food (formerly
``Feed'') Regulatory Program Standards (AFRPS) and Egg Regulatory
Program Standards (ERPS). In the United States, Federal and State
government agencies ensure the safety of human and animal food. FDA is
responsible for ensuring that all human and animal food moving in
interstate commerce, except those under the U.S. Department of
Agriculture jurisdiction, are safe, wholesome, and labeled properly.
States are responsible for conducting inspections and regulatory
activities that help ensure human and animal food a produced,
processed, and distributed within their jurisdictions are safe and in
compliance with State laws and regulations. States primarily perform
inspections under their own regulatory authority. Some States conduct
inspections of human and animal food facilities under contract with
FDA. Because jurisdictions may overlap, FDA and States collaborate and
share resources to protect human and animal food.
The FDA Food Safety Modernization Act calls for enhanced
partnerships and provides a legal mandate for developing an Integrated
Food Safety System (IFSS). FDA is committed to implementing an IFSS
thereby optimizing coordination of human and animal food safety efforts
with Federal, State, local, tribal, and territorial regulatory and
public health agencies. Model standards provide a consistent,
underlying foundation that is critical for uniformity across State and
Federal agencies to ensure credibility of human and animal food
programs within the IFSS. The AFRPS and ERPS provide a uniform and
consistent approach to animal food and egg regulation in the United
States. Implementation of the AFRPS and ERPS are voluntary.
The AFRPS and ERPS are the frameworks that each State should use to
design, manage, and improve its animal food or egg regulatory program.
The AFRPS standards include the following: (1) regulatory foundation;
(2) training program; (3) inspection program; (4) audit program; (5)
animal food-related illnesses or death and emergency response; (6)
compliance and enforcement program; (7) outreach program; (8) planning
and resources; (9) assessment and improvement; (10) laboratory
services; and (11) sampling program. The ERPS include equivalent
standards for egg regulatory programs except they do not include a
separate standard 11 sampling program. Each standard has a purpose
statement, requirement summary, description of program elements,
projected outcomes, and a list of required documentation. When a state
program voluntarily agrees to implement the standards, it must fully
implement and maintain the individual program elements and
documentation requirements in each standard in order to fully implement
the standard. We invite you to visit our website (<a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards</a>) for more information and to access the program
standards.
Both the AFRPS and ERPS package include forms, worksheets, and
templates to help the State program assess and meet the program
elements in the standard. State programs are not obligated to use the
forms, worksheets, and templates. Other manual or automated forms,
worksheets, and templates may be used as long as the pertinent data
elements are present. Records and other documents specified in the
AFRPS and ERPS must be maintained in good order by the state program
and must be available to verify the implementation of each standard.
As set forth in the AFRPS and ERPS, the state program is expected
to review and update its improvement plan on an annual basis. The state
program completes an evaluation of its implementation status at least
every 3 years following the baseline evaluation by reviewing and
updating the self-assessment worksheets and required documentation for
each standard. The evaluation is needed to determine if each standard's
requirements are, or remain, fully met, partially met, or not met. The
state program revises the improvement plan based upon this evaluation.
In collaboration with the State Governments, FDA recently completed
a revision of the animal food program standards that incorporated the
most current knowledge and lessons learned in the application of the
2020 AFRPS by State partners and program assessment by FDA. In an
effort to improve program effectiveness, understanding and clarity,
changes to the AFRPS include those to program definitions, all 11
program standards, appendices and assessment worksheets that may be
used by the States who have adopted the AFRPS. Such changes include
updates to terminology, most notably replacing the term ``animal feed''
with ``animal food'' consistent with the terminology of the FDA Food
Safety Modernization Act, and minor editorial changes. Other changes
include streamlining both the standards and appendices to be less
prescriptive in nature and better focus on information capture needs.
This process results in an overall reduction of 11 appendices (most of
which provided more program specific guidance or examples and therefore
are not expected to change the burden) and a reformatting of the
remaining
[[Page 66309]]
appendices to be more uniform, succinct and tabular in structure. The
revised program standards are the result of external collaboration and
coordination between FDA and the Association of American Feed Control
Officials (AAFCO) in which we consider any formal comments received on
the 2020 edition of the program standards and feedback obtained from
our collaboration with the States. A copy of the revised program
standards is available in the docket.
Description of Respondents: Respondents are State Departments of
Agriculture or Health enrolled in the AFRPS or ERPS (State
Governments).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Type of respondents; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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State, local, Territorial, and/ 25 1 25 569 14,225
or Tribal Governments;
submission of data elements to
FDA consistent with AFRPS......
State, local, Territorial and/or 10 1 10 569 5,690
Tribal Governments; submission
of data elements to FDA
consistent with ERPS...........
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Total....................... .............. .............. .............. .............. 19,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Type of respondents; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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State, local, Territorial, and/ 25 11 275 40 11,000
or Tribal Governments;
submission of data elements to
FDA consistent with AFRPS......
State, local, Territorial and/or 10 10 100 40 4,000
Tribal Governments; submission
of data elements to FDA
consistent with ERPS...........
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Total....................... .............. .............. .............. .............. 15,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
No change in burden is expected to be incurred with the
implementation of the revised AFRPS. However, we have adjusted the
number of respondents to the information collection associated with the
AFRPS to reflect a reduction in enrollment since our last evaluation.
In addition, based on the Agency's experience over the past 3 years, we
have added reporting burden and adjusted the recordkeeping burden
estimates associated with the AFRPS and ERPS, resulting in an increase
in responses and burden hours.
Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23919 Filed 11-2-22; 8:45 am]
BILLING CODE 4164-01-P
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